Preformulation and Stability Studies of Biotherapeutics Using DSC

The use of biotherapeutics, such as antibodies and other protein molecules, to treat diseases is a rapidly growing field in the pharmaceutical industry.Biotherapeutics are often required at high concentrations and multiple doses, hence a manufacturer must produce kilogram quantities or more of the protein drug. The manufacturing process for biotherapeutics involves protein expression in thousands of liters of bioreactor medium followed by a purification process using large-scale chromatography columns and filtration systems.